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Completed

NCT Number: NCT06165692

The Use of Platelet-rich-fibrin in Lower Third Molar Surgery.

The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.

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Key information

Conditions

Facial Swelling Stomatognathic Diseases Tooth Avulsion Tooth Diseases Tooth Extraction Status Nos Tooth Injuries Tooth Position Anomalies Tooth, Impacted Wounds and Injuries

Age range

18 year–32 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magna Graecia University of Catanzaro

Catanzaro, 88100, Italy

About this study

The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial. Facial swelling will be assessed using an innovative three-dimensional digital technique.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 to 32 years who required both M3M extractions were recruited
  • Good health status
  • Indication to surgical extraction of both M3M
  • Complete root formation
  • Surgical risk level classified as "Conventional" or "Moderate" according to Daugela et al. classification

Exclusion criteria

  • Person under the age of 18 or over 32
  • Allergy or contraindications to administration of corticosteroids
  • Acute infection in any of the teeth to be extracted
  • Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
  • Pregnancy or breastfeeding
  • History of treatment with antiresorptive drugs
  • Chronic kidney disease

Treatment and study plan

PRF

Biological

Post-operative PRF placement in the post-extraction socket after third molar surgery

Primary outcomes

  1. Facial swelling qualitative analysis

    Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

    To compare the effectiveness of PRF in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) .

  2. Facial swelling quantitative analysis - volumetric differences

    Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

    To compare the effectiveness of PRF in reducing facial swelling using quantitative three-dimensional analysis ( volumes measured in cm3) .

  3. Facial swelling quantitative analysis - linear differences

    Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

    To compare the effectiveness of PRF in reducing facial swelling using quantitative three-dimensional analysis (linear differences measured in cm2) .

Secondary outcomes

  1. Trismus analysis

    Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

    To assess the effects of PRF administration on trismus (measured in cm)

  2. Pain analysis with Visual analogue scale (VAS)

    Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

    To assess the effects of PRF administration on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome)

Sponsors and collaborators

Lead sponsor

Amerigo Giudice

Other

Registry information

Official study title

The Use of Platelet-rich-fibrin in Lower Third Molar Surgery: a Split-mouth Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2023
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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